Overview of CRI Lifetree's Centers of Excellence
A Range of Facilities for a Spectrum of Needs
CRI Lifetree's Centers of Excellence are strategically designed to promote safe and efficient execution of your Phase I-IV projects. From simple to complex, our three Centers of Excellence are secured research facilities with flexible space to house subjects in a variety of settings based on the specific considerations of each project and sponsor.
Private rooms within a psychiatric hospital, private, semi-private, small and large dorm style areas in our free standing secure research facilities allow us to uniquely house research subjects in a safe, well-controlled environment where subject safety always comes first.
Investigators are ever present on the units leading a team of professional; competency based trained staff, actively supported by real time quality control.
Limited access drug rooms, crash carts, fully equipped processing laboratories complete with calibrated, generator backed-up equipment, treatment rooms for specialized surgical techniques and state-of the-art monitoring systems are all part our Centers of Excellence.
In-house subjects enjoy wireless internet on a private, secure system, satellite TV, personal DVD players, catered meals, recreational areas and a team of dedicated liaisons that provide scheduled activities and team up to meet the needs of daily living while subjects are housed within our facilities which increases overall project compliance for lengthy in-house stays.
CRI Lifetree Specialized Services
Cerebral Spinal Fluid Sampling
The rationale for Cerebral Spinal Fluid (CSF) sampling in a research setting differs from clinical practice sampling when CSF is done for diagnostic purposes. First, the presence of biological molecules in CSF is a reflection of physiological or pathological CNS processes and as such is used as biomarkers of those processes. Second, CSF sampling is used to determine drug concentration in CSF compartment as the result of penetration of the drug across the blood brain barrier and their CNS PK profile. When the two are combined, changes in biomarkers can be used to monitor disease modification due to effects of study drugs. CRI Lifetree Salt Lake City's expertise in sampling CSF allows assaying concentrations of the parent compound, drug metabolites and disease modifying biomarkers. Sampling can be obtained from a single lumbar puncture and from int;ermittent or continuous, or both sampling from an indwelling catheter for up to 96 hours.
Novel Pain Model Development
CRI Lifetree is in the forefront of leveraging experimental pain models in healthy volunteers to demonstrate efficacy early in the drug development process. The cold pressor, a model of acute pain, is robustly sensitive to the analgesic activity of opiates (Koltzenburg et al., 2006; Escher et al., 2007) whereas contradicting results are observed with NSAIDs (Jones et al., 1988; Compton et al., 2003). A combination of heat plus capsaicin, induces a type of cutaneous sensitization that models neuropathic pain conditions such as post-herpetic neuralgia and diabetic peripheral neuropathy (Dirks et al., 2003). Heat/capsaicin-induced hyperalgesia and allodynia are sensitive to opioids, local anesthetics, and antiepileptic drugs such as gabapentin and pregabalin (Dirks et al., 2000; Petersen et al., 2001; Dirks et al., 2002; Gottrup et al., 2004; Wang et al., 2008). Quantitative sensory testing (QST) is carried out utilizing a Neurometer® which allows CRI Lifetree physicians and staff to explore different pain modalities transmitted by distinct populations of nerve fibers (Sakai et al., 2006).
CRI Lifetree Salt Lake City staff contributed in pioneering the development of the post-operative bunionectomy acute pain model and the associated methodology that has been presented to the FDA and is now widely used in the analgesic drug development process.
CRI Lifetree Salt Lake City is the leading site in the US for human pain model development. The Scientific Leadership in Salt Lake City is Miroslav "Misha" Backonja, MD and Lynn Webster, MD. Together with the strong clinical team in Salt Lake, we have conducted 8 studies using these models. Our physicians have deep collaborative relationships with Neuropathic Pain Research Consortium.Our expertise includes the following models:
Human Pain Models Proposed Mechanisms
- UVB burn (UVB)
- Intra-dermal (ID) capsaicin and Cold pressor test (CPT)
Human Pain Models Can Determine:
- UVB burn (UVB) - peripheral
- Intra-dermal (ID) capsaicin – peripheral and central
- Cold pressor test (CPT) - central
- Whether NCE has any analgesic properties
- Dose-range finding
- Whether NCE is peripherally or centrally acting with implication to inform which clinical pain disease models to proceed with in later phases
- Most appropriate outcome measures to carry into later phases
CRI Lifetree understands the ever changing drug development market and the need for novel pain model development and progress. CRI Lifetree Salt Lake City is uniquely qualified to offer cutting edge technology and methodologies to provide you with innovative clinical trial models.
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Staff and Training
CRI Lifetree Investigators are qualified by education, training, appropriate licensure, and experience to assume responsibility for the proper conduct of each clinical investigation. Our Investigator's are fully engaged daily along with other contributing members of the Project Team providing attentive medical over sight, ensuring ICH and GCP are the basis of the clinical staff's data collection efforts. Our Investigators are recognized thought leaders, provide consulting services, protocol design and development and are sought after to speak internationally.
CRI Lifetree's therapeutically focused Project Teams are the foundation for a successful project regardless of the size and scope and ensures a careful and deliberate project plan is organized to optimize each project's execution from study start-up to final deliverable. This will ensure that the needs of our clients are recognized and will clearly define administrative, operational, clinical and medical roles within each Center of Excellence and each project.
Project and therapeutic specific training are both critical element of CRI Lifetree's overall Training Program. This detailed training is led by our Therapeutic Leaders, Project Managers and/or Investigators. Our highly trained Project Teams staffs our Center's of Excellence 24 hours a day, 7 days a week with documented processes in place to ensure critical project and subject safety communications are acknowledged between shifts.
Each Project Team member at CRI Lifetree has an individualized company required Training Curriculum that is designed to appropriately train them based on job description and specific project roles and responsibilities. The competency based fully documented Training Program incorporates, in part, NIH, GCP, ICH and FDA Regulation training. All fulltime staff, including investigators are required to complete BLS and ACLS certification. Emergency mock drills, Company Standing Operating Procedures and Work Instructions confirm CRI Lifetree's commitment to GCP and subject safety.
Research pharmacy staffs contribute to our depth and scope of services we provide to our clients consisting of sterile and non-sterile compounding, batch records, packaging, labeling, randomization, IP Chain of Custody, accountability and storage requirements specific to your project. Laboratory staffs are IATA trained, utilize PK Chain of Custody procedures to ensure the quality of the samples we draw, process and store for our clients.
Marlton, NJ Center of Excellence:
The Marlton Research Center is a free-standing 60-bed research facility located in Marlton, N.J, strategically positioned to reach the tri-state population base of 41 million.
The multidisciplinary Marlton team consisting of psychiatrists, psychiatric nurses, Ph.D.s psychometricians and expert clinical support staff work seamlessly together to enroll and execute Phase I-IV pediatric, adolescent and adult psychiatry and neurology studies. The specialty features of the Marlton Center of Excellence offers private and semiprivate rooms, a sequestered area available for pediatric or geriatric patients and their caretakers, a first-in-human area with its own observation, PK room, three processing laboratories and a true state-of-the-art halon gas fire suppression room for the storage of all confidential and regulatory documents.
Marlton's Clinical LeadershipSteven J. Glass, M.D.
Philadelphia Research Center of Excellence:
Our inpatient and outpatient Philadelphia Research Center of Excellence is strategically located within the historic Kirkbride Center, an acute care psychiatric hospital in Philadelphia. The multidisciplinary Philadelphia team consisting of psychiatrists, psychiatric nurses, Ph.D.s psychometricians and expert clinical support staff work seamlessly together to enroll and execute Phase I-IV pediatric, adolescent and adult psychiatry and neurology studies.
The specialty features of the Philadelphia Center of Excellence offers 24 private and semiprivate rooms, sequestered areas for pediatric or geriatric patients and their caretakers, private areas for consenting and cognition testing.
Philadelphia's Clinical LeadershipDaniel Gruener, MDM
David G. Krefetz, D.O.
Mark Novitsky, M.D.
Salt Lake City Center of Excellence
Salt Lake City's Center of Excellence foot print has grown steadily since our inception in 2003 as Lifetree Clinical Research®. We now occupy three buildings on our research campus strategically located to attract study participants from the four corner area, which includes a population of 16 million. Our flexible clinical pharmacology unit is a carefully designed 110 bed investigative unit that supports the precise execution of analgesia, abuse liability, neuroscience, phase I research including first I human and human model development. Our clinical pharmacology unit is 27,000 square feet and provides flexible space where private, semi-private and dorm style rooms may be easily re-configured to accommodate the simple to most complex clinical trial with sequestered area for unique assessments.
Lifetree's Research Center has been FDA audited three times over the course of 11 years, most recently in January of 2010 with no 483's.
Our dedicated outpatient facility supports our CNS team and provides private rooms for rating; cognition testing and MedAvante assessments.
Our Clinical Trial Management Team reside in our 5,000 square foot building and houses state of the art monitoring rooms, 4 project managers and our data management team.
Salt Lake City Clinical LeadershipLynn R. Webster, M.D.
Miroslav "Misha" Bačkonja, M.D.